Journal of Traditional Chinese Medicine ›› 2026, Vol. 46 ›› Issue (5): 1276-1285.DOI: 10.19852/j.cnki.jtcm.2026.05.020
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Analysis of risk factors for anti-tuberculous drug-induced liver injury in treatment-naïve pulmonary tuberculosis patients with different Traditional Chinese Medicine syndromes: a retrospective study
CHEN Huan1,2, XU Chunjun2(
), NIU Zuohu2, LIU Shuo3, LIU Ye1
- 1
Department of Traditional Chinese Medicine ,Daxing Teaching Hospital, Capital Medical University Beijing 102600, China
2Department of Infections ,Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China
3Department of Pharmacy ,Beijing Chest Hospital, Capital Medical University Beijing 101149, China
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Received:2025-05-31Accepted:2026-01-21Online:2026-10-15Published:2026-10-09 -
Contact:Prof. XU Chunjun, Department of Infections, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China. xucj1409@126.com,Telephone: +86-13601372632
Cite this article
CHEN Huan, XU Chunjun, NIU Zuohu, LIU Shuo, LIU Ye. Analysis of risk factors for anti-tuberculous drug-induced liver injury in treatment-naïve pulmonary tuberculosis patients with different Traditional Chinese Medicine syndromes: a retrospective study[J]. Journal of Traditional Chinese Medicine, 2026, 46(5): 1276-1285.
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Figure 1 Patients selection flow chart AT-DILI: Anti-TB drug-induced liver injury.
Figure 1 Patients selection flow chart AT-DILI: Anti-TB drug-induced liver injury.
Table 1 Comparison of general characteristics in treatment-naïve pulmonary TB patients with different TCM syndromes ($\bar{x}$ ± s)
| Variable | Total (n = 632) | PYD (n = 304) | HFYD (n = 102) | DQY (n = 182) | DYY (n = 44) | P value | |
|---|---|---|---|---|---|---|---|
| Age (years) | 46±20 | 42±18 | 40±19 | 52±20 | 66±16 | <0.001 | |
| Gender [n (%)] | Male | 398 (63) | 178 (59) | 63 (62) | 132 (73) | 25 (57) | 0.015 |
| Female | 234 (37) | 126 (41) | 39 (38) | 50 (27) | 19 (43) | ||
| BMI (kg/m2) | 21±4 | 20±4 | 19±3 | 19±3 | 22±3 | <0.001 | |
| Smoke [n (%)] | No | 415 (66) | 205 (67) | 74 (73) | 164 (90) | 28 (59) | 0.132 |
| Yes | 217 (34) | 99 (33) | 28 (27) | 18 (10) | 18 (41) | ||
| Alcohol [n (%)] | No | 523 (83) | 254(83) | 89 (87) | 143 (79) | 37 (84) | 0.276 |
| Yes | 109 (17) | 50 (17) | 13 (13) | 39 (21) | 7 (16) | ||
| Allergy [n (%)] | No | 574 (91) | 272 (90) | 99 (97) | 164 (90) | 38 (86) | 0.055 |
| Yes | 58 (9) | 31 (10) | 3(3) | 18 (10) | 6 (14) | ||
| Diabetes [n (%)] | No | 497 (79) | 239 (79) | 87 (85) | 134 (74) | 37 (84) | 0.103 |
| Yes | 135 (21) | 65 (21) | 15 (15) | 48 (26) | 7 (16) | ||
Table 1 Comparison of general characteristics in treatment-naïve pulmonary TB patients with different TCM syndromes ($\bar{x}$ ± s)
| Variable | Total (n = 632) | PYD (n = 304) | HFYD (n = 102) | DQY (n = 182) | DYY (n = 44) | P value | |
|---|---|---|---|---|---|---|---|
| Age (years) | 46±20 | 42±18 | 40±19 | 52±20 | 66±16 | <0.001 | |
| Gender [n (%)] | Male | 398 (63) | 178 (59) | 63 (62) | 132 (73) | 25 (57) | 0.015 |
| Female | 234 (37) | 126 (41) | 39 (38) | 50 (27) | 19 (43) | ||
| BMI (kg/m2) | 21±4 | 20±4 | 19±3 | 19±3 | 22±3 | <0.001 | |
| Smoke [n (%)] | No | 415 (66) | 205 (67) | 74 (73) | 164 (90) | 28 (59) | 0.132 |
| Yes | 217 (34) | 99 (33) | 28 (27) | 18 (10) | 18 (41) | ||
| Alcohol [n (%)] | No | 523 (83) | 254(83) | 89 (87) | 143 (79) | 37 (84) | 0.276 |
| Yes | 109 (17) | 50 (17) | 13 (13) | 39 (21) | 7 (16) | ||
| Allergy [n (%)] | No | 574 (91) | 272 (90) | 99 (97) | 164 (90) | 38 (86) | 0.055 |
| Yes | 58 (9) | 31 (10) | 3(3) | 18 (10) | 6 (14) | ||
| Diabetes [n (%)] | No | 497 (79) | 239 (79) | 87 (85) | 134 (74) | 37 (84) | 0.103 |
| Yes | 135 (21) | 65 (21) | 15 (15) | 48 (26) | 7 (16) | ||
Table 2 Comparison of biochemical indicators in treatment-naïve pulmonary TB patients with different TCM syndromes ($\bar{x}$ ± s)
| Variable | Total (n = 632) | PYD (n = 304) | HFYD (n = 102) | DQY (n = 182) | DYY (n = 44) | P value | |
|---|---|---|---|---|---|---|---|
| Hydrothorax [n (%)] | No | 515 (81) | 273 (90) | 78 (76) | 131 (72) | 33 (75) | <0.001a |
| Yes | 117 (19) | 31 (10) | 24 (24) | 51 (28) | 11 (25) | ||
| HGB (g/L) | 123.92±20.76 | 120.70±19.93 | 116.39±18.54 | 119.62±22.25 | 128.38±20.14 | 0.357b | |
| PLT (×109/L) | 283.92±95.45 | 284.08±97.02 | 298.80±119.02 | 309.41±99.17 | 273.12±87.72 | 0.012b | |
| ALB (g/L) | 35.97±5.38 | 34.08±5.14 | 33.82±4.79 | 35.60±5.33 | 37.54±5.15 | <0.001b | |
| CHE (U/L) | 6245.17±1949.48 | 5632.48±2061.57 | 5494.45±1883.43 | 5883.53±1907.90 | 6841.97±1717.62 | <0.001b | |
| TBA (μmol/L) | 5.46±5.92 | 5.55±3.95 | 5.83±3.83 | 5.59±4.58 | 5.31±7.39 | 0.060b | |
| CHOL (mmol/L) | 3.85±0.87 | 3.87±0.92 | 3.80±0.88 | 3.81±0.78 | 3.86±0.86 | 0.943b | |
| TG (mmol/L) | 1.31±1.62 | 1.26±0.96 | 1.99±4.96 | 1.09±0.53 | 1.33±1.11 | 0.201b | |
| LDL-C (mmol/L) | 2.80±0.80 | 2.85±0.83 | 2.70±0.86 | 2.77±0.76 | 2.79±0.79 | 0.891b | |
| LDH (U/L) | 170.54±49.03 | 179.33±52.30 | 183.20±66.91 | 166.74±44.75 | 164.72±44.28 | 0.009b | |
| CRP (U/L) | 30.26±38.81 | 39.72±43.71 | 30.69±31.28 | 30.36±36.38 | 24.46±36.42 | <0.001b | |
| PT (S) | 10.82±1.14 | 10.97±1.18 | 11.15±1.02 | 11.02±1.09 | 10.61±1.13 | 0.410b | |
| INR | 0.94 ±0.18 | 0.94±0.11 | 0.96±0.09 | 0.95±0.10 | 0.93±0.24 | <0.001b | |
| APTT (S) | 29.86±6.08 | 30.92±6.40 | 31.72±5.61 | 30.73±5.38 | 28.65±5.96 | <0.001b | |
| TT (S) | 19.58±1.84 | 19.50±2.08 | 19.67±2.06 | 19.44±1.18 | 19.65±1.84 | 0.006b | |
| D-dimer (mg/L) | 1.54±2.31 | 2.17±2.86 | 2.06±2.55 | 2.05±2.54 | 0.92±1.54 | <0.001b | |
Table 2 Comparison of biochemical indicators in treatment-naïve pulmonary TB patients with different TCM syndromes ($\bar{x}$ ± s)
| Variable | Total (n = 632) | PYD (n = 304) | HFYD (n = 102) | DQY (n = 182) | DYY (n = 44) | P value | |
|---|---|---|---|---|---|---|---|
| Hydrothorax [n (%)] | No | 515 (81) | 273 (90) | 78 (76) | 131 (72) | 33 (75) | <0.001a |
| Yes | 117 (19) | 31 (10) | 24 (24) | 51 (28) | 11 (25) | ||
| HGB (g/L) | 123.92±20.76 | 120.70±19.93 | 116.39±18.54 | 119.62±22.25 | 128.38±20.14 | 0.357b | |
| PLT (×109/L) | 283.92±95.45 | 284.08±97.02 | 298.80±119.02 | 309.41±99.17 | 273.12±87.72 | 0.012b | |
| ALB (g/L) | 35.97±5.38 | 34.08±5.14 | 33.82±4.79 | 35.60±5.33 | 37.54±5.15 | <0.001b | |
| CHE (U/L) | 6245.17±1949.48 | 5632.48±2061.57 | 5494.45±1883.43 | 5883.53±1907.90 | 6841.97±1717.62 | <0.001b | |
| TBA (μmol/L) | 5.46±5.92 | 5.55±3.95 | 5.83±3.83 | 5.59±4.58 | 5.31±7.39 | 0.060b | |
| CHOL (mmol/L) | 3.85±0.87 | 3.87±0.92 | 3.80±0.88 | 3.81±0.78 | 3.86±0.86 | 0.943b | |
| TG (mmol/L) | 1.31±1.62 | 1.26±0.96 | 1.99±4.96 | 1.09±0.53 | 1.33±1.11 | 0.201b | |
| LDL-C (mmol/L) | 2.80±0.80 | 2.85±0.83 | 2.70±0.86 | 2.77±0.76 | 2.79±0.79 | 0.891b | |
| LDH (U/L) | 170.54±49.03 | 179.33±52.30 | 183.20±66.91 | 166.74±44.75 | 164.72±44.28 | 0.009b | |
| CRP (U/L) | 30.26±38.81 | 39.72±43.71 | 30.69±31.28 | 30.36±36.38 | 24.46±36.42 | <0.001b | |
| PT (S) | 10.82±1.14 | 10.97±1.18 | 11.15±1.02 | 11.02±1.09 | 10.61±1.13 | 0.410b | |
| INR | 0.94 ±0.18 | 0.94±0.11 | 0.96±0.09 | 0.95±0.10 | 0.93±0.24 | <0.001b | |
| APTT (S) | 29.86±6.08 | 30.92±6.40 | 31.72±5.61 | 30.73±5.38 | 28.65±5.96 | <0.001b | |
| TT (S) | 19.58±1.84 | 19.50±2.08 | 19.67±2.06 | 19.44±1.18 | 19.65±1.84 | 0.006b | |
| D-dimer (mg/L) | 1.54±2.31 | 2.17±2.86 | 2.06±2.55 | 2.05±2.54 | 0.92±1.54 | <0.001b | |
Figure 2 Comparison of case counts between patients with AT-DILI and those with normal liver function across four TCM syndrome groups PYD: pulmonary Yin deficiency; HFYD: hyperactivity of fire due to Yin deficiency; DQY: deficiency of Qi and Yin; DYY: deficiency of Yin and Yang. AT-DILI: anti-tuberculosis drug-induced liver injury; TCM: Traditional Chinese Medicine. Statistical comparisons within each TCM syndrome group were performed using the χ 2 test. aP < 0.001, bP < 0.01 vs the normal group within the same syndrome.
Figure 2 Comparison of case counts between patients with AT-DILI and those with normal liver function across four TCM syndrome groups PYD: pulmonary Yin deficiency; HFYD: hyperactivity of fire due to Yin deficiency; DQY: deficiency of Qi and Yin; DYY: deficiency of Yin and Yang. AT-DILI: anti-tuberculosis drug-induced liver injury; TCM: Traditional Chinese Medicine. Statistical comparisons within each TCM syndrome group were performed using the χ 2 test. aP < 0.001, bP < 0.01 vs the normal group within the same syndrome.
Table 3 Comparison of biochemical markers in patients with liver injury across different TCM syndromes ($\bar{x}$ ± s)
| Variable | Total (n = 246) | PYD (n = 110) | HFYD (n = 36) | DQY (n = 87) | DYY (n = 13) | P value |
|---|---|---|---|---|---|---|
| AST (U/L) | 53.4±35.3 | 57.0±43.4 | 46.1±13.7 | 39.3±24.4 | 55.3±31.3 | 0.218 |
| ALT (U/L) | 40.1±27.8 | 43.2±30.2 | 28.9±9.3 | 37.4±26.4 | 39.6±27.5 | 0.792 |
| ALP (U/L) | 107.8±47.1 | 110.5±52.8 | 136.5±71.5 | 121.5±41.9 | 98.5±38.0 | 0.082 |
| TBIL (μmol/L) | 12.4±7.0 | 12.8±7.2 | 13.7±8.6 | 8.8±4.7 | 12.9±7.0 | 0.057 |
| DBIL (μmol/L) | 4.2±3.1 | 4.5±3.3 | 5.9±4.7 | 2.8±1.9 | 4.1±2.9 | 0.033 |
| IBIL (μmol/L) | 8.2±4.6 | 8.2±4.5 | 7.8±4.2 | 5.9±3.1 | 8.8±4.8 | 0.085 |
| GGT (U/L) | 48.6±40.6 | 55.6±46.7 | 64.5±72.1 | 37.2±30.8 | 44.4±31.7 | 0.257 |
| TBA (μmol/L) | 8.0±8.9 | 9.0±9.9 | 18.5±18.8 | 6.0±5.5 | 6.6±6.0 | 0.026 |
| TIME (days) | 43.6±41.0 | 48.8±48.2 | 31.4±44.5 | 30.5±24. 5 | 44.5±37.5 | 0.263 |
Table 3 Comparison of biochemical markers in patients with liver injury across different TCM syndromes ($\bar{x}$ ± s)
| Variable | Total (n = 246) | PYD (n = 110) | HFYD (n = 36) | DQY (n = 87) | DYY (n = 13) | P value |
|---|---|---|---|---|---|---|
| AST (U/L) | 53.4±35.3 | 57.0±43.4 | 46.1±13.7 | 39.3±24.4 | 55.3±31.3 | 0.218 |
| ALT (U/L) | 40.1±27.8 | 43.2±30.2 | 28.9±9.3 | 37.4±26.4 | 39.6±27.5 | 0.792 |
| ALP (U/L) | 107.8±47.1 | 110.5±52.8 | 136.5±71.5 | 121.5±41.9 | 98.5±38.0 | 0.082 |
| TBIL (μmol/L) | 12.4±7.0 | 12.8±7.2 | 13.7±8.6 | 8.8±4.7 | 12.9±7.0 | 0.057 |
| DBIL (μmol/L) | 4.2±3.1 | 4.5±3.3 | 5.9±4.7 | 2.8±1.9 | 4.1±2.9 | 0.033 |
| IBIL (μmol/L) | 8.2±4.6 | 8.2±4.5 | 7.8±4.2 | 5.9±3.1 | 8.8±4.8 | 0.085 |
| GGT (U/L) | 48.6±40.6 | 55.6±46.7 | 64.5±72.1 | 37.2±30.8 | 44.4±31.7 | 0.257 |
| TBA (μmol/L) | 8.0±8.9 | 9.0±9.9 | 18.5±18.8 | 6.0±5.5 | 6.6±6.0 | 0.026 |
| TIME (days) | 43.6±41.0 | 48.8±48.2 | 31.4±44.5 | 30.5±24. 5 | 44.5±37.5 | 0.263 |
Table 4 Comparison of liver function laboratory indicators and time in AT-DILI patients with different TCM syndromes ($\bar{x}$ ± s)
| Variable | Total (n = 89) | PYD (n = 39) | HFYD (n = 16) | DQY (n = 29) | DYY (n = 5) | P value |
|---|---|---|---|---|---|---|
| AST (U/L) | 109±45 | 116±56 | 121±55 | 120±41 | 97±33 | 0.428 |
| ALT (U/L) | 40±28 | 433±30 | 25±8 | 38±25 | 41±29 | 0.799 |
| ALP (U/L) | 53±32 | 60±41 | 47±17 | 41±25 | 53±28 | 0.28 |
| TBIL (μmol/L) | 5±4 | 5±4 | 6±5 | 3±2 | 5±3 | 0.101 |
| DBIL (μmol/L) | 49±43 | 61±56 | 48±27 | 40±33 | 45±36 | 0.109 |
| IBIL (μmol/L) | 8±5 | 8±4 | 7±3 | 6±3 | 10±5 | 0.126 |
| GGT (U/L) | 9±10 | 10±12 | 25±21 | 7±6 | 7±6 | 0.565 |
| TBA (μmol/L) | 13±7 | 13±8 | 13±8 | 10±5 | 14±7 | 0.093 |
| TIME (days) | 40±40 | 49±51 | 11±9 | 25±17 | 43±38 | 0.055 |
Table 4 Comparison of liver function laboratory indicators and time in AT-DILI patients with different TCM syndromes ($\bar{x}$ ± s)
| Variable | Total (n = 89) | PYD (n = 39) | HFYD (n = 16) | DQY (n = 29) | DYY (n = 5) | P value |
|---|---|---|---|---|---|---|
| AST (U/L) | 109±45 | 116±56 | 121±55 | 120±41 | 97±33 | 0.428 |
| ALT (U/L) | 40±28 | 433±30 | 25±8 | 38±25 | 41±29 | 0.799 |
| ALP (U/L) | 53±32 | 60±41 | 47±17 | 41±25 | 53±28 | 0.28 |
| TBIL (μmol/L) | 5±4 | 5±4 | 6±5 | 3±2 | 5±3 | 0.101 |
| DBIL (μmol/L) | 49±43 | 61±56 | 48±27 | 40±33 | 45±36 | 0.109 |
| IBIL (μmol/L) | 8±5 | 8±4 | 7±3 | 6±3 | 10±5 | 0.126 |
| GGT (U/L) | 9±10 | 10±12 | 25±21 | 7±6 | 7±6 | 0.565 |
| TBA (μmol/L) | 13±7 | 13±8 | 13±8 | 10±5 | 14±7 | 0.093 |
| TIME (days) | 40±40 | 49±51 | 11±9 | 25±17 | 43±38 | 0.055 |
Figure 3 Univariate logistic regression analysis of risk factors for AT-DILI across TCM syndrome groups A: PYD group; B: HFYD group; C: DQY group; D: DYY group. PYD: pulmonary Yin deficiency; HFYD: hyperactivity of fire due to Yin deficiency; DQY: deficiency of Qi and Yin; DYY: deficiency of Yin and Yang. All patients in the four TCM syndrome groups received the same standardized first-line anti-tuberculosis regimen consisting of 2 months of isoniazid, rifampicin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampid and rifampicin (2HRZE/4HR), with dosages adjusted according to body weight. AT-DILI, anti-tuberculosis drug-induced liver injury; TCM: Traditional Chinese Medicine; OR: odds ratio; CI: confidence interval; TT: thrombin time; ALB: albumin; LDH: lactate dehydrogenase; PLT: platelet count; CHE: cholinesterase; CRP: C-reactive protein; APTT: activated partial thromboplastin time; D-Dimer: D-dimer. Univariate logistic regression was performed with AT-DILI as the dependent variable (1 = yes, 0 = no). Data are expressed as OR with 95% CI. The vertical line in each forest plot represents OR = 1 (no association). The sample sizes were 304 for PYD, 102 for HFYD, 182 for DQY, and 44 for DYY. Statistical significance was defined as a two-sided P < 0.05, with a P < 0.01 and b P < 0.05 indicated in the figure.
Figure 3 Univariate logistic regression analysis of risk factors for AT-DILI across TCM syndrome groups A: PYD group; B: HFYD group; C: DQY group; D: DYY group. PYD: pulmonary Yin deficiency; HFYD: hyperactivity of fire due to Yin deficiency; DQY: deficiency of Qi and Yin; DYY: deficiency of Yin and Yang. All patients in the four TCM syndrome groups received the same standardized first-line anti-tuberculosis regimen consisting of 2 months of isoniazid, rifampicin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampid and rifampicin (2HRZE/4HR), with dosages adjusted according to body weight. AT-DILI, anti-tuberculosis drug-induced liver injury; TCM: Traditional Chinese Medicine; OR: odds ratio; CI: confidence interval; TT: thrombin time; ALB: albumin; LDH: lactate dehydrogenase; PLT: platelet count; CHE: cholinesterase; CRP: C-reactive protein; APTT: activated partial thromboplastin time; D-Dimer: D-dimer. Univariate logistic regression was performed with AT-DILI as the dependent variable (1 = yes, 0 = no). Data are expressed as OR with 95% CI. The vertical line in each forest plot represents OR = 1 (no association). The sample sizes were 304 for PYD, 102 for HFYD, 182 for DQY, and 44 for DYY. Statistical significance was defined as a two-sided P < 0.05, with a P < 0.01 and b P < 0.05 indicated in the figure.
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